Actively Recruiting
Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Led by Alpha Tau Medical LTD. · Updated on 2026-05-06
40
Participants Needed
15
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to: * Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
CONDITIONS
Official Title
Alpha Radiation Emitters Device (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) or metastatic pancreatic adenocarcinoma (Cohort 2)
- Starting treatment with mFOLFIRINOX (up to 4 cycles) before Alpha DaRT placement
- Tumor lesion suitable for Alpha DaRT source implantation
- Measurable lesion according to RECIST version 1.1
- Lesion size 5 cm or less in longest diameter
- Interstitial radiation indication approved by multidisciplinary team
- ECOG performance status between 0 and 2
- Life expectancy greater than 6 months
- White blood cell count of at least 3500/µl and granulocytes at least 1500/µl
- Platelet count of at least 60,000/µl
- Creatinine level 1.9 mg/dL or less
- AST and ALT levels no greater than 2.5 times upper limit of normal
- INR less than 1.4 for patients not on Warfarin
- Age 18 years or older
- Able and willing to sign informed consent
- Women of childbearing potential must have a negative pregnancy test before Ra-224 implantation and use acceptable contraception for 3 months after Alpha DaRT therapy starts
- Agreement to use adequate contraception (vasectomy or barrier methods) before and during the study and for 3 months after DaRT insertion
You will not qualify if you...
- For Cohort 1 only: Borderline unresectable pancreatic cancer or eligible for surgery unless surgery is refused
- Prior treatments for pancreatic cancer other than 1 to 4 cycles of mFOLFIRINOX chemotherapy
- Known allergy to any study treatment components
- Current systemic immunosuppressive therapy except short-term corticosteroids
- Significant cardiovascular diseases such as severe heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or recent heart attack within 12 months
- Uncontrolled illnesses including active infections requiring systemic therapy or psychiatric/substance abuse disorders interfering with study participation
- Active additional malignancies that require treatment, except certain skin cancers, low-risk prostate cancer, or in situ cervical cancer
- Need for treatments not specified in the study that may interfere with evaluating DaRT response or toxicity
- Refusal or inability to use adequate contraception during study and for 3 months after DaRT insertion
- Participation in another interventional study within 30 days that conflicts with this study
- High risk of not following the study protocol
- Breastfeeding women or women unwilling or unable to use contraception for 3 months after DaRT insertion
- Increased risk of radiation complications due to genetic mutations, inflammatory bowel disease, or connective tissue diseases
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
City of Hope
Goodyear, Arizona, United States, 85338
Not Yet Recruiting
3
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
4
Cedars-Sinai
Los Angeles, California, United States, 90048
Not Yet Recruiting
5
Advent Health Cancer Institute
Orlando, Florida, United States, 32804
Not Yet Recruiting
6
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
7
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Lenox hill Hospital
New York, New York, United States, 10075
Not Yet Recruiting
10
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
11
Texas Oncology
Houston, Texas, United States, 75251
Not Yet Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77054
Not Yet Recruiting
13
University Cancer and Diagnostic
Houston, Texas, United States, 77089
Actively Recruiting
14
Jewish General Hospital
Montreal, Quebec, Canada
Not Yet Recruiting
15
Hadassah Ein Kerem
Jerusalem, Israel
Actively Recruiting
Research Team
L
Liron Dimnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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